Study of Belatacept in Subjects Who Are Undergoing a Renal Transplant

PHASE3CompletedINTERVENTIONAL
Enrollment

595

Participants

Timeline

Start Date

February 28, 2005

Primary Completion Date

May 31, 2008

Study Completion Date

September 30, 2014

Conditions
Renal Transplantation
Interventions
DRUG

Cyclosporin A

tablet, oral, 1st month target: 150-300 ng/mL, after 1st month target: 100-250 ng/mL, daily, 36 months, 100-250 ng/mL, daily, 84 months

DRUG

Belatacept Less Intensive Regimen (LI)

solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months months, 5 mg/kg every 4 weeks, q 4 weeks, 84 months

DRUG

Belatacept More Intensive Regimen (MI)

solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months, 5 mg/kg every 4 weeks, q 4 weeks, 84 months

Trial Locations (79)

1082

Local Institution, Budapest

1090

Local Institution, Vienna

1425

Local Institution, Capital Federal

2000

Local Institution, Rosario

3000

Local Institution, Leuven

5011

Local Institution, Woodville

6020

Local Institution, Innsbuck

10029

Mount Sinai School Of Medicine, New York

10032

Columbia University College Of Physicians & Surgeons, New York

10117

Local Institution, Berlin

13083

Local Institution, Campinas/sp

13353

Local Institution, Berlin

19102

Drexel University College Of Medicine, Department Of Surgery, Philadelphia

19104

University Of Pennsylvania, Philadelphia

20162

Local Institution, Milan

21041

Local Institution, Rio de Janeiro

27599

University Of North Carolina At Chapel Hill, Chapel Hill

28040

Local Institution, Madrid

28041

Local Institution, Madrid

28203

Carolinas Medical Center, Charlotte

29010

Local Institution, Málaga

29609

Local Institution, Brest

30309

Piedmont Transplant Institute, Atlanta

30322

Emory University Hospital, Atlanta

30625

Local Institution, Hanover

31054

Local Institution, Toulouse

33076

Local Institution, Bordeaux

33606

Lifelink Healthcare Institute, Tampa

35128

Local Institution, Padua

35294

University Of Alabama At Birmingham, Birmingham

37044

Local Institution, Tours

44093

Local Institution, Nantes

45147

Local Institution, Essen

48202

Henry Ford Hospital, Transplant Institute, Detroit

53226

Froedtert Memorial Hospital, Milwaukee

53792

University Of Wisconsin, Madison

54511

Local Institution, Vandœuvre-lès-Nancy

55455

University Of Minnesota, Minneapolis

60611

Northwestern University-Feinberg School Of Medicine, Chicago

60637

University Of Chicago Hospitals, Chicago

63110

Washington University School Of Medicine, St Louis

70112

Tulane Abdominal Transplant Institute, New Orleans

70563

Acadiana Renal Physicians, New Iberia

75015

Local Institution, Paris

75246

Baylor University Medical Center, Dallas

80045

University Of Colorado Health Sciences Center, Aurora

90024

Ucla Kidney & Kidney-Pancreas Transplant Research Office, Los Angeles

90035

Local Institution, Porto Alegre

Local Institution, Porto Alegre/rs

90057

National Institute Of Transplantation, Los Angeles

91054

Local Institution, Erlangen

92133

Sharp Memorial Hospital, San Diego

94000

Local Institution, Créteil

94143

University Of California San Francisco Medical Center, San Francisco

94275

Local Institution, Le Kremlin-Bicêtre

06540

Yale University School Of Medicine, New Haven

02215

Beth Israel Deaconess Medical Center, Boston

01107

Western New England Renal & Transplant Associates, Pc, Springfield

C1155APP

Local Institution, Capital Federal

X5016KEH

Local Institution, Cordoba, Crd

S3000EPV

Local Institution, Santa Fe

05403

Local Institution, São Paulo

4038-002

Local Institution, São Paulo

T6G 2S2

Local Institution, Edmonton

B3H 1V7

Local Institution, Halifax

H3A 1A1

Local Institution, Montreal

S7M 0Z9

Local Institution, Saskatoon

Unknown

Local Institution, Santiago

140 21

Local Institution, Prague

H-6720

Local Institution, Szeged

00168

Local Institution, Roma

N-0027

Local Institution, Oslo

60-479

Local Institution, Poznan

02-006

Local Institution, Warsaw

0181

Local Institution, Pretoria

08036

Local Institution, Barcelona

08907

Local Institution, Barcelona

413 45

Local Institution, Gothenburg

M13 9WL

Local Institution, Manchester

Sponsors
All Listed Sponsors
lead

Bristol-Myers Squibb

INDUSTRY